'Refuse-To-Accept' Policy Outlined For De Novos In New US FDA Draft Guidance
Executive Summary
Following a user fee deal that will subject de novo applications to performance goals and user-fee payments, US FDA has proposed a guidance that attempts to explain its process for considering when to accept, and when not to accept, a de novo submission for review.
You may also be interested in...
Minding The Middle: FDA Fleshes Out De Novo Regs As The Program Expands
A new proposed rule on the de novo classification process does not advance any major policy reforms, but its release underscores the growing popularity of the regulatory pathway that provides flexibility for US FDA and industry in the space between 510(k)s and PMAs.
US Approvals Analysis: Original PMA Slowdown, De Novo Upswing Among Recent Trends
The volume of original PMAs coming to US FDA for review is down recently, while panel-track supplement, de novo and 510(k) volumes are up. October, meanwhile, was a relatively light month for novel device approvals, but better-than-average for 510(k) clearances.
De Novo Policies Clarified In Final Guidance
A US FDA final guidance incorporates a 21st Century Cures Act provision that does away with a 30-day submission requirement for post-NSE de novo classification submissions and makes other clarifications.